Tunneled Catheter with Hemostasis Mechanism

ABSTRACT

A hemostasis component for an invasive medical device has an inflatable cylinder affixed to the medical device at a location aligned with an ingress point of a patient. An inflation source is in fluid communication with the inflatable cylinder and a flow control valve that is effective to regulate the flow of fluid from the inflation source to the inflatable cylinder is provided. The flexible cylinder is located on the proximal end of a tunneling catheter, where it exits the skin. A thin tube is provided to inflate the flexible cylinder. In the event of bleeding, the flexible cylinder is inflated for as long as is needed to achieve hemostasis, without having to place sutures. Inflation is a simple procedure that can be done by the patient, as opposed to having to place a suture, which must be performed by a physician or a physician&#39;s delegate, under sterile conditions.

CROSS REFERENCE TO RELATED APPLICATION(S)

N.A.

U.S. GOVERNMENT RIGHTS

N.A.

BACKGROUND

1. Field

This disclosure relates to medical devices having a hemostasiscomponent. More particularly, an expandable sleeve on the proximate endof a catheter is effective to stanch blood flow.

2. Description of the Related Art

Patients with end stage renal disease (ESRD) often require long termhemodialysis which is performed using a surgically placed AV fistula, aconnection between a vein and an artery. While a patient is waiting forfistula surgery, or if the fistula is not working properly, dialysis canbe performed via a tunneled catheter, also referred to as a permcath.

The catheter is a large bore catheter (15-16 French size) which istunneled from the subcutaneous tissues of the chest wall, and theninserted into the internal jugular vein (or other large vein) usinginterventional radiology techniques. Exemplary is the Quinton™ Permcath™Dual Lumen Catheter (trademark of Covidien, Mansfield, MA) that providesblood flow rates of 350-400 mL/min and maintains low arterial and venouspressures. The catheter is made of a soft, silicone material and isdesigned with a staggered tip to provide a 2.5 cm separation between thearterial lumen and venous tip. The catheter is provided in a variety ofinsertion lengths to accommodate different patient anatomies andphysician insertion practices.

The process of tunneling the catheter involves attaching the catheter toa long metal tunneling device which bores through the subcutaneoustissues. The tunneling process is traumatic as small blood vessels inthe subcutaneous tissues are torn by the tunneling device causingbleeding out of the tunnel track. This is even more problematic inpatients with ESRD, as their blood does not clot as well due to problemswith platelet function, which is necessary to adequately clot the blood.Physicians are often called to deal with bleeding from the permcathsite. Medical intervention can be time consuming, as it requiresanything from holding pressure to putting in sutures in order to stopthe bleeding. Sutures must be removed at some point because skin damagecan occur if the sutures remain for an extended period of time.

Devices for promoting hemostasis in a blood vessel puncture aredisclosed in U.S. Pat. No. 5,904,147 to Conlan et al. and in U.S. Pat.No. 6,071,300 to Brenneman et al. Both U.S. Pat. No. 5,904,147 and U.S.Pat. No. 6,071,300 are incorporated by reference herein in theirentireties.

Accordingly, there remains a need for an improved tunneling catheter forhemodialysis and others functions that has an improved hemostasiscomponent.

BRIEF SUMMARY

It is an object of certain embodiments disclosed herein to provide aballoon, or other inflatable member, located on the proximal end of thepermcath, where it exits the skin. A thin tube is provided to inflatethe balloon. In the event of bleeding, the balloon can be inflated foras long as is needed to achieve hemostasis, without having to placesutures. Inflating the balloon is a very simple procedure that can evenbe done by the patient themselves, as opposed to having the place asuture, which must be performed by a physician or a physician's delegatesuch as a physician's assistant, under sterile conditions.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a permcath ingress into subcutaneous tissues of achest wall as known from the prior art.

FIG. 2 illustrates a tunneling device for use with a permcath as knownfrom the prior art.

FIG. 3 illustrates the tunneling device of FIG. 2 attached to a permcathas known from the prior art.

FIG. 4 illustrates a permcath ingress into subcutaneous tissues of achest wall where the permcath includes a hemostasis component.

FIG. 5 illustrates a portion of the permcath of FIG. 4 prior todeployment of the hemostasis component.

FIG. 6 illustrates the portion of the permcath of FIG. 5 subsequent todeployment of the hemostasis component.

Like reference numbers and designations in the various drawingsindicated like elements.

DETAILED DESCRIPTION

As used herein, an “invasive medical device” is one that is intended topuncture the skin of a subject when used its intended manner. “Subject”refers to any mammal, human or non-human and the invasive devises areequally applicable to medical and veterinary procedures.

FIG. 1 illustrates a tunneled catheter 10, also referred to a permcath,inserted into a patient 12 with ingress 14 being through the chest wall.The permcath 10 is tunneled through subcutaneous tissue 16 of the chestwall for insertion into a jugular vein 18. FIG. 2 shows a tunnelingdevice 20 for use with a permcath. The tunneling device 20 is formedfrom a hard biocompatible material, such as stainless steel, and has adistal end 22 that comes to a point effective for boring throughsubcutaneous tissue. An opposing proximal end 24 contains features, suchas threads, for engagement with the permcath. FIG. 3 shows the proximalend 24 of the tunneling device 20 fastened to a distal end 26 ofpermcath 28. An anchoring cuff 29 is disposed at a location, that onproper insertion, will be in the subcutaneous tissue, close to theingress. The anchoring cuff 29 both fixes the positioning of thepermacath 28 and functions as a bacteria blocker to prevent bacteriafrom entering the patient 12 through the ingress 14.

Referring back to FIG. 1, the tunneling process is traumatic and smallblood vessels in the subcutaneous tissue 16 are torn causing bleedingthat flows along the tunnel track and exits the patient 12 at ingress14. With reference to FIG. 4, a hemostasis component 30 is affixed to aproximal end 32 of the permcath 28. In the event of bleeding, thehemostasis component 30 is inflated for as long as is needed to achievehemostasis, without having to place sutures.

FIG. 5 illustrates the hemostasis component 30 affixed to the proximalend 32 of a permcath adjacent anchoring cuff 29. The diameter, D, of thehemostasis component is sufficient small to permit insertion into theingress (14 of FIG. 1). The hemostasis component 30 typically has ahollow cylindrical shape and is formed from biocompatible flexiblematerial such as silicone, PET (polyethylene terephthalate) or nylon. Aninflation tube 34 is in fluid communication with the interior of thehemostasis component 30. The inflation tube is also in fluidcommunication with an inflation source 36, such as a syringe. A flowcontrol valve 38 regulates the flow of fluid from the inflation source36 to the hemostasis components 30 and out from the hemostasiscomponents when bleeding has stopped, typically in about 15 minutes. Asan inflated hemostasis component may compress the proximal end 32 of thecatheter reducing its inside diameter, the hemostasis component ispreferably deflated prior to commencing a flow of fluids through thecatheter.

Referring to FIG. 6, in the event there is bleeding at the ingress (14in FIG. 1), a fluid, such as air, purified water or a saline solution,is conducted via inflation tube 34 to the hemostasis component 30inflating the hemostasis component to a diameter, D′. D′ is slightlylarger than the diameter of the ingress to apply a positive pressureagainst the subcutaneous tissue immediately below the ingress to therebystanch the bleeding.

Referring back to FIG. 3, the hemostasis component may be an inflatablecylinder located on either side of the anchoring cuff 29, or be a doublecylinder positioned on either side of the anchoring cuff. Alternatively,the hemostasis component may be an expandable foam material or a coatingof a drug that promotes hemostasis, such as thrombin.

One or more embodiments of the present invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and broad scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

What is claimed is:
 1. A hemostasis component for an invasive medicaldevice, comprising: an inflatable cylinder affixed to said medicaldevice at a location aligned with an ingress point of a subject whensaid medical device is fully inserted; an inflation source in fluidcommunication with said inflatable cylinder; and a flow control valveeffective to regulate the flow of fluid from said inflation source tosaid inflatable cylinder.
 2. The hemostasis component of claim 1 whereinsaid inflatable cylinder is manufactured from silicone.
 3. Thehemostasis component of claim 2 wherein said fluid is saline.
 4. Thehemostasis component of claim 3 affixed to a proximal end of a tunnelingcatheter adjacent a first side of an anchor cuff
 5. The hemostasiscomponent of claim 4 wherein a second inflatable cylinder is affixed tosaid medical device adjacent an opposing second side of said anchor cuff6. A tunneled catheter comprising: a tunneling device affixed to adistal end of a catheter; and a hemostasis component affixed to aproximal end of said catheter.
 7. The tunneled catheter of claim 6wherein said hemostasis component is an inflatable foam.
 8. The tunneledcatheter of claim 6 wherein said hemostasis component is a chemicalcompound having efficacy to promote hemostasis.
 9. The tunneled catheterof claim 8 wherein said chemical compound is thrombin.
 10. The tunneledcatheter of claim 6 wherein said hemostasis component is an inflatablecylinder.
 11. The tunneling catheter of claim 10 wherein an inflationsource is in fluid communication with said hemostasis component and aflow control valve is effective to regulate the flow of a fluid fromsaid inflation source to said hemostasis component.
 12. The tunnelingcatheter of claim 11 wherein said fluid is selected from the groupconsisting of saline, purified water, and inert gases thereof
 13. Thetunneling catheter of claim 11 wherein said hemostasis component isformed from a flexible biocompatible material.
 14. The tunnelingcatheter of claim 13 wherein said flexible biocompatible material isselected from the group consisting of silicone, polyethyleneterephthalate and nylon.
 15. The tunneling catheter of claim 11 being ahemodialysis catheter.